Free Testosterone ELISA

GUDID 04049016137740

EUROIMMUN Medizinische Labordiagnostika AG

Free testosterone IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04049016137740
NIH Device Record Key64527d90-b424-4cea-b916-ddf2ca0d9efb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFree Testosterone ELISA
Version Model NumberEQ 6151-9601
Company DUNS322209263
Company NameEUROIMMUN Medizinische Labordiagnostika AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104049016137740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CDZRadioimmunoassay, Testosterones And Dihydrotestosterone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-05-03
Device Publish Date2022-12-08

Devices Manufactured by EUROIMMUN Medizinische Labordiagnostika AG

04049016137894 - IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern2024-09-19
04049016151999 - Mounting medium (IFA)2024-07-25
04049016144595 - IFA: Oesophagus (Monkey) IgA EUROPattern2024-05-27
04049016125228 - EUROArrayScanner2023-11-28
04049016159704 - EUROPLUS Granulocyte Mosaic 322023-10-13
04049016159018 - UNIQO 1602023-09-28
04049016152989 - IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern2023-07-13
04049016069355 - Adjustment solution2023-06-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.